CN115768361A

CN115768361A - Suturing device

Info

Publication number: CN115768361A
Application number: CN202180042773.4A
Authority: CN
Inventors: D·J·林登; M·J·拉文斯克罗夫特; T·杜尼
Original assignee: Arthrex Inc
Current assignee: Arthrex Inc
Priority date: 2020-06-16
Filing date: 2021-03-29
Publication date: 2023-03-07
Also published as: WO2021257149A2; EP3925544A1; WO2021257149A3; EP4164506A2; US20230099945A1; AU2021293512A1

Abstract

A stitching device is provided with at least one weft strand interwoven with a plurality of warp strands to define a body region. The body region has a substantially open mesh configuration and at least a first elongate end region extends axially from and is a part of the body region, the at least first elongate end region having a substantially closed mesh configuration. The width of the end region is substantially less than the width of the body region.

Description

Suturing device

Technical Field

The present invention relates to a medical device, which may be a suturing device for orthopedic repair, such as reattaching a muscle or ligament to tissue that has been detached therefrom, anchoring a graft and repair device to underlying tissue, or reconstructing damaged or torn tissue.

Background

Conventional surgical techniques require the use of sutures to engage soft tissue such as tendons or ligaments or hard tissue such as bone. Sutures are typically configured to have a relatively small diameter, which results in a small contact area and a high contact force, which may cause the suture to cut into adjacent tissue.

Disclosure of Invention

The problem to be solved is to provide a reinforced suture tape with a flatter and wider profile and provide improved utility for a range of surgical applications while allowing use with existing instruments, improved contact pressure during surgical repair, and the ability to integrate with adjacent tissue.

The solution to the problem is described in the independent claims. The dependent claims relate to further developments.

In a first embodiment, a seaming apparatus is provided that includes at least one weft yarn strand interwoven with a plurality of warp yarn strands to define a body region having a substantially open mesh configuration and at least a first elongate end region extending axially from and being a part of the body region, the first elongate end region having a substantially closed mesh configuration and a width that is substantially less than a width of the body portion. The suturing device can include a body region located between adjacent first and optionally second end regions. The configuration of the body region may provide resistance to tissue pull-through, and the configuration of the adjacent end regions allows manipulation of the device during a surgical procedure.

Typically, an open mesh configuration has a larger pore size than a closed mesh configuration. The aperture may be defined by the largest opening between adjacent weft and warp strands. The average pore size is defined as the average of a plurality of pore sizes of the same pore type. The open mesh configuration may be characterized by an average pore size or substantially each pore size of at least 100 μm, which may allow for cellular nutrition while supporting cell migration and proliferation leading to tissue repair. The target aperture may be 0.3mm or 0.5mm. The pore size may be less than 1mm or 2mm.

The closed mesh configuration may be characterized by an average pore size or substantially each pore size of less than 100 μm, which may allow packaging of the woven fabric into a compressed size to support its use with existing surgical instruments.

The body region and the at least one end region may comprise a woven fabric. Woven fabrics are intended to encompass a wide variety of configurations, both interwoven and non-interwoven, whether made by weaving, knitting, crocheting, braiding, twisting, plying, embroidering, bonding, laminating, non-woven or other processes and combinations thereof. The textile construction may be made of strands. The term "strand" is intended to include fibers, monofilaments, multifilament yarns which may or may not be twisted, woven constructions such as braids, or combinations of these. The strands may have a uniform or varying shape or size. The strands may be composed of a uniform material or a combination of materials. The discrete strands may comprise the same material or different materials. The variation between strands in configuration, shape, size, material, coating or mechanical properties may be equally geometric arrangement or may be irregularly spaced.

The device may include a plurality of interwoven strands comprising a plurality of warp threads, which may be aligned substantially parallel to the longitudinal axis. It may also include a plurality of weft yarns that may be aligned substantially transverse to the longitudinal axis. The weft yarns may be provided by a single weft yarn strand extending through the warp yarns. The weft strands may extend back and forth through the device substantially perpendicular relative to the longitudinal axis of the device and partially along edge portions of the device substantially parallel to the longitudinal axis of the device. The weft strands may be thicker than the warp strands. The weft yarns may be substantially hollow. The warp yarns may be arranged in adjacent pairs and may be interwoven with the weft yarn strands to form a leno weave construction (which is also referred to as a gauze weave or cross weave). The strands may include plied fibers. The leno weave may comprise at least two warp strands twisted in a series of splays around at least one weft strand, wherein a first warp strand passes under a weft strand and over a second warp strand, and the second warp strand passes over a weft strand.

In embodiments, the device comprises a second elongated end region extending axially from and being one part with the body region in a direction opposite to the first end region.

Further, the device may comprise a tapered transition region defined between and being one part of the body region and/or the end region.

In an embodiment, the plurality of warp strands comprises a plurality of groups of at least two warp strands.

In embodiments, the plurality of sets of warp strands may comprise a plurality of adjacent pairs of warp strands.

In an embodiment, a first warp strand of the plurality of sets of warp strands is substantially planar and a second warp strand of the plurality of sets of warp strands is interwoven with the at least one weft strand.

In an embodiment, a set of warp strands comprises a greater number of the first warp strands than the second warp strands.

In embodiments, the thickness of the first warp strand is greater than the thickness of the second warp strand.

In embodiments, the sets of warp strands of the body region are substantially parallel and spaced apart to define an open mesh configuration.

In embodiments, the at least one weft yarn strand extending through at least a portion of the body region and/or at least a portion of the at least one end region comprises a plurality of weft yarn strands.

In embodiments, at least one end portion of the body region comprises a plurality of weft strands, while a central portion of the body region comprises a single weft strand.

In an embodiment, both end portions of the body region comprise a plurality of weft yarn strands.

In embodiments, at least one of the weft strands of at least one end portion of the body region is made relatively rigid, while the weft strands of a central portion of the body region are relatively flexible.

In an embodiment, the relatively rigid weft yarn strand comprises a braided rope and the relatively flexible weft yarn strand comprises at least one filament.

In an embodiment, a first weft yarn strand of the plurality of weft yarn strands is thicker than a second weft yarn strand of the plurality of weft yarn strands.

In embodiments, at least one weft strand extends substantially longitudinally from a portion of the main body region.

In embodiments, at least one weft strand extends substantially along at least one edge of the central portion of the body region.

In embodiments, at least one weft strand extends substantially along opposing edges of a central portion of the body region.

In embodiments, each weft yarn extends through a separate aperture of a warp yarn.

In embodiments, the at least one weft strand of the at least one end region comprises at least one cabled construction.

In embodiments, at least one end portion of the at least one corded construction is substantially hollow.

In embodiments, the free ends of the warp strands of at least one end region are located inside at least one cabled construction by one or more splices to define at least one cabled end region.

In embodiments, at least one weft yarn strand is provided by a cabled construction.

In embodiments, at least one warp yarn strand is provided by a cabled construction.

In an embodiment, a first part of the free ends of the warp strands of at least one end region are located inside the first cabled configuration by means of one or more twist linkers to define a first cabled end region, while a second part of the free ends of the warp strands of at least one end region are located inside the second cabled configuration by means of one or more twist linkers to define a second cabled end region.

In an embodiment, the first and second corded end regions are joined to form at least one looped end region.

In embodiments, the length of the at least one looped end region can be adjusted by passing at least a first corded end region within a second corded end region.

In embodiments, the length of the at least one looped end region can be adjusted by passing at least one of the first and second corded end regions therein.

In embodiments, one or more securing buttons are attached to at least one annular end region.

In embodiments, the body region is substantially planar or tubular.

In accordance with another embodiment, a method of manufacturing a suturing apparatus is provided. The method comprises the following steps:

interweaving at least one weft strand with a plurality of warp strands to define a substantially open mesh configuration; and

applying tension to at least one weft strand to push the warp strands together and define a body region having a substantially open mesh configuration and at least a first elongate end region extending axially from and being a part of the body region, the at least first elongate end region having a substantially closed mesh configuration and a width substantially less than the width of the body portion.

In embodiments, the method comprises providing a tapered transition region between the body region and/or the end region, the tapered transition region being one part with the body region and/or the end region.

In an embodiment, the method comprises providing a plurality of sets of at least two warp strands, wherein a first warp strand of a set of warp strands is substantially planar and a second warp strand of a set of warp strands is interwoven with at least one weft strand.

In an embodiment, interlacing comprises extending a plurality of weft strands through at least a portion of the body region and/or at least a portion of at least one end region.

In an embodiment, the method comprises positioning free ends of the warp strands of the at least one end region inside the cabled and hollow configuration of the at least one weft strand by one or more splices to define the at least one cabled end region.

In embodiments, the method comprises positioning free ends of the warp strands of the at least one end region inside the cabled and hollow configurations of the at least one warp strand by one or more splices to define the at least one cabled end region.

In an embodiment, the method comprises cutting at least one end region of the warp yarn strands that are pushed together in proximity.

In embodiments, the method comprises binding the free ends of the warp strands and/or the at least one weft strand together.

Drawings

Hereinafter, the present invention will be described by way of examples of embodiments with reference to the accompanying drawings, without limiting the general inventive concept.

FIG. 1 shows a suture;

FIG. 2a shows the configuration of the suturing device during a first stage of manufacture;

FIG. 2b shows the configuration of the suturing device during another stage of manufacture;

FIG. 3 shows another suture;

FIG. 4 illustrates the configuration of the body region of the first suture;

FIG. 5 shows the configuration of the body region of the second suture thread;

FIG. 6 shows the configuration of the body region of the third suture;

FIG. 7 shows a configuration of a body region of a fourth suture;

FIG. 8 shows the configuration of the body region of a fifth suture thread;

FIG. 9 shows a configuration of a body region of a sixth suture thread;

FIG. 10a shows the configuration of a seventh suture during a first stage of manufacture;

FIG. 10b shows the construction of a seventh suture during another stage of manufacture;

FIG. 10c shows the construction of a seventh suture during another stage of manufacture;

FIG. 11a shows a configuration of an eighth suture;

FIG. 11b shows a configuration of a ninth suture;

FIG. 12a shows a tenth suture configuration;

FIG. 12b shows a configuration of an eleventh suture;

FIG. 12c shows a twelfth suture configuration;

FIG. 12d shows a configuration of a thirteenth suture thread;

fig. 13a to 13c illustrate a method of manufacturing a suture;

14a to 14c show the configuration of the body region of another suture;

fig. 15 a-15 b show another embodiment with a modified warp yarn cord.

Fig. 16a to 16b show another embodiment.

Fig. 17a and 17b schematically show how the aperture may be defined.

Detailed Description

As shown in fig. 1, a surgical stapling device 100 in accordance with an embodiment includes a continuous length of stapling material. The suture material has one or more regions of defined configuration. The device includes a body region 102 located between adjacent first end regions 104 and optional second end regions 106. The configuration of the body region provides resistance to tissue pull-through, and the configuration of the adjacent end regions allows manipulation of the device during a surgical procedure. The body region may have a substantially flat, circular or tubular profile. It may be made of sheet material, woven fabric or a combination of these constructions. Between the end and body regions tapered transition regions 108,110 are provided.

Suitably, the body region 102 and at least one end region 104,106 comprise a woven fabric. Woven fabrics can include a variety of configurations of interwoven and non-interwoven, whether made by weaving, knitting, crocheting, braiding, twisting, plying, embroidering, bonding, laminating, non-woven or other processes and combinations thereof. The textile construction may be made of strands. The term "strand" is intended to include fibers, monofilaments, multifilament yarns which may or may not be twisted, woven constructions such as braids, or combinations of these. The strands may have a uniform or varying shape or size. The strands may be composed of a uniform material or a combination of materials. The discrete strands may be the same material or different materials. The variation between strands may be equally geometric in configuration, shape, size, material, coating or mechanical properties, or may be irregularly spaced.

As shown in fig. 2a, device 200 suitably comprises a plurality of interwoven strands comprising a plurality of warp strands 250 (aligned substantially parallel to the longitudinal axis) and a plurality of weft strands 252 (aligned substantially transverse to the longitudinal axis). Suitably, the weft yarns are provided by individual weft yarn strands extending through the warp yarns. Suitably, as shown, the weft strands extend back and forth through the device substantially perpendicularly relative to the longitudinal axis of the device and partially along edge portions of the device that are substantially parallel to the longitudinal axis of the device. Suitably, the weft strands are thicker than the warp strands. Suitably, the weft yarns are substantially hollow. Suitably, the warp yarns are arranged in adjacent pairs and are interwoven with the weft yarn strands to form a leno weave construction (also known as a gauze weave or cross weave). Suitably, the strands comprise plied fibers.

Fig. 2b shows an embodiment with loose strands at least one of the ends. One or both ends may have loose strands comprising loose warp yarns and/or loose weft yarns. The at least one weft yarn strand may be substantially parallel to the warp yarn strands, but may not be wrapped around and/or twisted together with the warp yarn strands. As shown in fig. 2b, the body region 202 and at least one end region 204 may be formed by pulling the weft strands 252 out of the configuration to form one pass. The stroke may be pulled until the weft yarn engages and locks to the warp strands 250, which pulls the warp strands toward the central longitudinal axis of the device and forms a tapered transition region 208 between the body region 202 and the at least one end region 204. The loose strands at the ends of the at least one end region 204 may be suitably coated with wax, silicone, PTFE, adhesive, or the like, to bond them together. Desirably, the first end region and the second end region may be integral with the body region to provide a continuous suturing device. The end regions may comprise a body section that is unraveled, which body section may also comprise loose warp yarns (free ends of the warp strands) and loose weft yarns, wherein the weft yarns reside in the longitudinal direction. The resulting structure may then be modified in various ways to form the end regions. This may include coating/gelling the loose longitudinal warp and weft strands together. Another example may include twisting loose warp strands into loose longitudinal weft yarns, but this second process is only possible if the weft yarns have a hollow tubular structure. This tubular structure may likewise be provided by braiding, knitting or weaving.

As shown in fig. 3, a surgical stapling system 300 in accordance with an embodiment includes a continuous length of stapling material. The body region 302 comprises a woven construction, suitably a leno weave construction, having a plurality of warp yarns and one or more weft yarns, preferably comprising a cord construction. The weft cords are provided by interlaced strands of knitted, braided or woven construction. Suitably, the weft yarn rope is of a braided construction having a circular hollow profile. Preferably, the strands comprise plied fibers. Preferably, the weft yarn cords change orientation as they extend along the device from one region to an adjacent region. For example, as shown, the latitudinal ribs extend back and forth across the device (substantially perpendicular to the longitudinal axis) and extend a relatively short distance along the edge portions of the device and substantially parallel to the longitudinal axis. The weft cords may comprise a flat (or tubular) woven construction for a wider body area (as opposed to a flat, densely packed braid), wherein the woven fabric is formed from a plurality of warp yarns positioned parallel to the long axis of the device that are wrapped with one or more weft yarns extending at approximately 90 degrees to the longitudinal axis. The weft yarns have a relatively wide cross-section compared to the warp strands and are also hollow tubes which act as hollow sutures.

A tapered transition 308 between the body region 302 and the end region 304 is formed by pulling the weft yarn cord in a substantially longitudinal direction (i.e., applying tension to the weft yarn cord) and pulling it out of the construction to provide a stroke that locks the warp strands and pulls them toward the central axis. The weft strands are oriented substantially parallel to the warp strands. The loose strands adjacent to the taper are suitably placed within the longitudinally oriented hollow weft yarn cord via a single or series of splices that run inside the length of the

end regions

304, 306, or terminate at a distance from the ends.

Regions

312 and 314 are the weft cords after being repositioned to the warp direction. The free end of the mesh of the main body region 302 is then pulled into this hollow tubular weft yarn cord. As shown in fig. 3, this mesh material travels a short distance inside the weft ribs, i.e., between the taper 310 at the end of the body 302 and the beginning of the end region 306, which may be relatively thin. Thus, the end regions 306 are identical weft cords without any mesh construction inside.

This stroke causes the weft cord to lock the warp yarns at the tapered section while providing the tapered section itself. This arrangement also allows for easier splicing, provides a smooth tapered transition from the body region 302 to the end region 306, which allows for easy passage through tissue, and provides a thin and dense string end to facilitate passage through a surgical instrument and formation of a fixation mechanism.

According to alternative embodiments, the surgical device may include an open mesh configuration that allows for a relatively wide profile to be formed from a similar amount of material. This provides increased coverage to enhance engagement with adjacent tissue and also promotes tissue ingrowth and post-operative repair.

As shown in fig. 4, body region 402 may include a mesh configuration with openings of similarly or equally spaced paired warp strands 450 to form a leno weave configuration. Warp strands 450 are interwoven with weft strands 452. The leno construction is different from the woven construction (although described with the same terms warp and weft). The main difference is that adjacent warp strands 450 (laid longitudinally) are twisted around each other in the area between consecutive individual weft strands 452 (laid transversely), which may form a helical pair or a series of splayings, effectively "locking" each weft strand 452 in place. Wherein the first warp strand of the helical pair always passes under weft strands 452 and over the second warp strand, and the second warp strand always passes over weft strands 452. In contrast, the warp strands in a woven construction do not wrap around each other and are similar to a linear orientation, with each warp strand passing under and over a consecutive weft strand. However, to achieve the strength desired for some applications, a large number of warp strands or relatively large warp strands may be provided per unit of fabric width, thereby reducing the aperture size, which in turn may impair tissue incorporation.

As shown in fig. 5, two or more sets of spaced pairs of adjacent warp strands 550 are provided which allow for the incorporation of more strands per fabric width, thereby increasing their strength, while also being able to increase pore size and optimize for tissue incorporation.

As shown in fig. 6, two or more sets of spaced apart pairs of adjacent warp strands 650 are provided, with one pair including "parallel" strands 651. For example, one strand 651 from a warp pair lies 'parallel' (substantially planar) in the fabric, while the other strand 653 of the warp pair interweaves with a weft strand 652, thereby joining the parallel warp and weft strands. The parallel warp strands bear a majority of the applied axial load, and because of their parallel orientation, this configuration provides increased resistance to elongation when placed under axial load.

Suitably, as shown in fig. 7, this configuration may incorporate a greater number of parallel warp strands 751 than 'binding' warp strands 753. This configuration may be desirable where increased fabric stiffness may be provided.

Preferably, parallel warp strands 751 have a larger diameter than binding warp strands 753. This allows the formation of particularly desirable fabrics with relatively high strength (large number of warp yarns), relatively high stiffness (parallel warp yarns) and optimal pore size for tissue incorporation.

Alternatively, one or more of the binding warp strands may have a similar, larger or smaller diameter than the other strands. One or more of the parallel warp strands may have a diameter similar to, greater than, or less than the other strands. One or more of the weft strands may have a similar, larger or smaller diameter than the other strands. One or more of the warp and/or weft strands may be equally spaced or unequally spaced. For example, as shown in fig. 14a, the transverse portions 1453 of the weft strands 1452 can be substantially parallel and equally spaced relative to one another. Alternatively, as shown in fig. 14b, the transverse portions 1453 of the weft strands 1452 can be substantially parallel to, but not equally spaced relative to, the other portion. Further alternatively, as shown in fig. 14c, the transverse portion 1453 of the weft strands 1452 can be non-parallel to the other portion.

According to alternative embodiments, the body region of the device may comprise an open mesh configuration and at least one end region may have a thinner configuration to facilitate passage through tissue and eyelets in the surgical instrument. As previously described, the thinner end region may be formed by a series of tapers, bonds and/or splices.

As shown in fig. 8, the body region 802 of the device according to an alternative embodiment may comprise an open mesh configuration comprising a plurality of

weft strands

852, 854 to form a leno weave configuration. This provides the ability for different configurations along the length of the device.

As shown in fig. 9, portions of body region 902 may have more or fewer weft yarns than adjacent portions. For example, the

end portions

903, 905 of the body region may have a plurality of weft strands, while the central portion 901 of the body region may have fewer weft strands. This provides a central portion 901 having a body region of optimized configuration for tissue incorporation and end

body portions

903, 905 having configurations for optimized coupling with bone, soft tissue, fixation devices, and the like. Alternatively, the central portion 901 has more weft strands than the

adjacent end portions

903, 905.

According to an alternative embodiment, as shown in fig. 10 a-10 c, one or more weft yarns in one or both ends of body region 1002 may comprise a woven rope into which warp yarns and additional weft yarns may be twisted to form end region 1004. The other weft strands are formed of filaments together with the warp strands, which provides a soft and pliable middle portion 1001 of the body region 1002 for enhancing tissue ingrowth, while the

end portions

1003, 1005 of the body region 1002 have an optimized configuration to help secure and form a transition to the end cords.

According to an alternative embodiment, the weft yarns in the

end portions

1103, 1105 of the main body region 1102 are continuous, with one or more weft yarns 1152 extending at least partially along an edge of the central portion 1101 of the main body region and substantially parallel to the longitudinal axis. This arrangement provides a soft and pliable middle portion for enhanced tissue ingrowth for the body region 1102, while the edge portions of the body region have the increased strength provided by the second weft yarns. Fig. 11a shows a device with one end region 1106 and fig. 11b shows a device with two

end regions

1104, 1106.

According to an alternative embodiment, multiple sets of weft yarns may be used. In a first example, as shown in fig. 12a, a first rope end 1260 is spliced together with the remaining weft and warp yarns within a second rope end 1262 to provide a single end region 1204. In a second example, as shown in fig. 12b, the weft cord is a discrete end to provide a pair of spaced apart end

portions

1204, 1205 extending from at least one end region of the device. In a third example, as shown in fig. 12c, the weft cords are discrete ends that are then spliced together to form a loop 1206. In a fourth example, as shown in fig. 12d, the weft cord is a discrete end that is then spliced to form an adjustable length loop 1207. This arrangement provides a fixation mechanism that allows the device to be attached to tissue. For example, the adjustable length loop may be formed by a weft yarn rope penetrating the stitching wall of the opposing weft yarn.

Weft yarn 1204 penetrates opposing weft yarn 1205, enters and resides along the inner cavity of opposing weft yarn 1205 at point 1208, and exits weft yarn 1205 at point 1210, forming a loop whose length is adjustable when the free end of cord 1211 is pulled and lockable when loop 1207 is under load. Similarly, weft yarn 1205 penetrates opposite weft yarn 1204 at point 1213, passes within weft yarn 1204, and exits weft yarn 1204 at point 1215 to form the free end of cord 1217. Alternatively, any weft cord may be formed into a discrete adjustable loop by passing within itself. Alternatively, buttons may be attached to one or more rings to aid in fixation.

According to an alternative embodiment, the device is suitably configured to facilitate removal of excess material after implantation. Typically, such open mesh configurations are unstable when cut to length, wherein the strands at the ends of the device can wear and splay as the fabric configuration unravels. A method is described by which device 1300 is cut to a first length (fig. 13 a), a stroke is formed by pulling weft strands 1352 until the weft strands bind and lock to warp strands 1350 (fig. 13 b), and then the device can be cut to a second length shorter than the first length while retaining the bound strands (fig. 13 c). This creates a stable end for the device that will not further unbond. Suitably, the spacing between adjacent channels of weft strands is set to facilitate this action. As an example, if a length of 16mm is required to pull the stroke before the binding, and if adjacent weft yarn channels are spaced 2mm apart, 8 weft yarn channels are counted backwards from the desired position and a first length cut is made and then the binding is positioned at the desired position, when the binding can be located at a specific position (e.g. adjacent to the binding). Suitably, the weft yarns have a larger diameter than the warp yarns and are formed of a woven construction and have a different colour to the warp yarns so that they are easily identifiable to facilitate this method.

According to an alternative embodiment, one or more warp cords may be used. In a first example, as shown in fig. 15a, a first warp cord 1502 extends along an edge of a central portion 1501 of the body region and is substantially parallel to the longitudinal axis. A second warp yarn rope 1503 extends along the opposite edge of the central portion 1501 of the body region.

Warp cords

1502, 1503 are paired with

warp strands

1506, 1507 to bind the warp cords to the body region. This arrangement provides a soft and pliable middle portion of the body region 1501 for enhanced tissue ingrowth, while the edge portions of the body region have the added strength provided by the warp cords. In a second example, as shown in fig. 15b, each warp cord 1555 is bound to the body area by one or more weft strands 1552 and adjacent paired warp yarn configurations 1550. Preferably, the end portion extending from at least one end region of the device is formed by splicing warp yarn cords and warp yarn filaments into one or more weft yarns which may comprise a woven cord. According to an embodiment, the end portion extending from at least one end area of the device is formed by twisting weft and warp filaments into one or more warp cords. According to an embodiment, the end portion extending from at least one end region of the device is formed by twisting weft yarn cords, warp yarn cords and warp filaments.

In fig. 16a and 16b, another embodiment is shown. While in the embodiment of fig. 8, the two weft strands pass through the same twist formed by a pair of warp strands, here each of the two weft strands may be defined by a separate twist. More weft strands may be defined by the same twist or different twists. The weft yarn strands may comprise yarns and/or a weave. In fig. 16a, an embodiment with two

similar weft strands

852, 853 is shown. Fig. 16b shows an embodiment with different types of

weft strands

852, 854.

The configuration of any region of the device with respect to width, length, cross-sectional shape, density, pore size, material type and mechanical properties may be adapted to its function, whereby the mechanical properties may comprise one or a combination of the following: strength, stiffness, wettability, flexibility and absorption rate, and any region may have a change in, for example, any one or combination of the above physical or mechanical properties. The variation in properties of the warp or weft strands may be substantially equally spaced or unequally spaced from each other. One or more of the warp strands may comprise a different cross-sectional size than the other warp strands. The warp strands may be equal to, greater than, and/or less than the denier of the weft strands. The body region of the device may have undulations in the surface to provide increased frictional resistance to assist in knotting. One or more of the warp strands may include a larger cross-sectional area to form one or more ridges. One or more of the weft strands may include a larger cross-sectional area to form one or more ridges. The cross-section of the body region may be planar or tubular.

The suture material may comprise a single material or a mixture of materials. The material from which the textile fabric is made may comprise bioabsorbable or non-bioabsorbable substances from natural or artificial sources, including, for example, intestine, silk, cotton, ultra High Molecular Weight Polyethylene (UHMWPE), polyamide (Nylon), polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), polydioxanone Polyetheretherketone (PEEK), polyetherketoneketone (PEKK), graphene or bioabsorbable materials, whether as a single material or as a mixture. A combination of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyethylene terephthalate (PET) may be used to provide strength and improved knotting characteristics, respectively. Paired warp strands may be used, one of which is UHMWPE and the other of which is PET. Preferably, the UHMWPE has a larger cross-sectional area, in fact a larger denier, and is substantially parallel to transfer loads, with smaller denier PET strands being used to bond the UHMWPE strands to the weft yarns. Colored strands may be incorporated to improve visibility during use. The colored strands are suitably made from dyed UHMWPE, PET or nylon fibers. Different regions may be identified using different colors or color patterns.

Embodiments provide a suturing device that provides improved utility for a range of surgical applications while allowing the device to be used with existing surgical instruments. The device is configured to improve the pressure distribution to adjacent tissue during and after surgical repair and reduce/eliminate any undesirable contact forces that may result in cutting of adjacent tissue. The device is configured to provide improved strength and optimized coupling with bone, soft tissue or fixation devices. The device includes a relatively wide and open mesh body region to form a large footprint that is resistant to tissue pull-through and to promote tissue interaction. The relatively thin end region is adapted to pass through a relatively small aperture in a standard surgical instrument to facilitate efficient passage through tissue during a surgical procedure.

Fig. 17a and 17b schematically show how the aperture may be defined. A portion of the embodiment of fig. 8 is used as an example, but the definition of aperture may apply to any of the embodiments disclosed herein.

The preferred definition is the diameter of the circle superimposed within the interstices between adjacent strands as shown in figure 17 a. The open pores have a circle with a diameter 866, which may be greater than 100 μm. The closed pores have a circle with a diameter 868, which may be less than 100 μm. Typically, the open aperture has a larger circle than the closed aperture.

If the distance of the weft strands is greater than the distance of the warp strands, the diameter of the circle is mainly determined by the distance of the warp strands. This is shown in fig. 17 b. The distance 858 of the smaller gap between weft yarns is approximately the same as the smaller circle 868. Further, the distance of the

larger gaps

856 and 857 is about the same as the larger circle 866. Thus, the distance between adjacent weft yarns can be used as a simplified measure of the aperture.

Claims

1. A suturing device (100), comprising:

a body region (102) comprising at least one weft strand (252) interwoven with a plurality of warp strands (250) in a leno weave, wherein the at least one weft strand (252) has a thickness greater than each warp strand of the plurality of warp strands (250), and

at least one elongated end region (104) extending axially from and being a part of the body region (102) and having a width smaller than the width of the body region (102),

at least one weft strand (252) interwoven with a plurality of warp strands (250) to define a body region (102) having a substantially open mesh configuration and at least a first elongate end region (104) extending axially from and being a part of the body region (102), the at least first elongate end region having a substantially closed mesh configuration and a width substantially less than a width of the body region (102), wherein the at least one elongate end region (104) comprises at least one of the at least one weft strand (252).

2. A suturing device (100), comprising:

wherein the average pore size of the body region (102) is greater than the average pore size of the at least one elongated end region (104).

3. A suturing device (100), comprising:

a body region (102) comprising at least one weft strand (252) interwoven with a plurality of warp strands (250) in a leno weave, wherein the at least one weft strand (252) has a thickness greater than each warp strand of the plurality of warp strands (250),

at least one elongated end region (104) extending axially from and being a part of the body region (102) and having a width smaller than the width of the body region (102), an

At least one tapered transition region (108, 110) defined between and being one part of the body region (102) and/or end region (104, 106), wherein

At least one warp yarn strand of the plurality of warp yarn strands (250) and at least one weft yarn strand (252) are joined to form an elongated end region (104).

4. The suturing device (100) according to claim 1,

the method is characterized in that:

the open mesh construction has an average pore size of more than 100 μm and the closed mesh construction has an average pore size of less than 100 μm.

5. The suturing device (100) according to claim 2,

the method is characterized in that:

the average pore size of the body region (102) is at least 100 μm and/or the average pore size of the at least one elongate end region (104) is less than 100 μm.

6. Suturing device (100) according to any one of the preceding claims,

the method is characterized in that:

the leno weave includes at least first and second warp strands twisted in a series of splays around at least one weft strand, wherein the first warp strand passes under the weft strand and over the second warp strand, and the second warp strand passes over the weft strand.

7. Suturing device (100) according to any one of the preceding claims,

the method is characterized in that:

the at least one weft yarn strand (252) is a suture, and/or

The at least one tapered transition region (108, 110) comprises at least one warp strand of the plurality of warp strands (250) spliced into the suture strand (252).

8. Suturing device (100) according to any one of the preceding claims,

the method is characterized in that:

a second elongated end region (106) extends axially from the body region (102) and is disposed in an opposite direction from the first end region (104) and is a part of the body region (102), and/or

At least one of the elongated end regions (104) is not corrugated and/or has a constant width.

9. Suturing device (100) according to any one of the preceding claims,

the method is characterized in that:

the plurality of warp strands (250) comprises a plurality of groups of at least two warp strands (250), wherein any one group of warp strands (250) comprises a plurality of adjacent pairs of warp strands (250), and/or

The sets of warp strands (250) of the body region (102) are parallel and spaced apart.

10. Suturing device (100) according to any one of the preceding claims,

the method is characterized in that:

a first warp strand (250) of a set of warp strands (250) is planar and a second warp strand (250) of the set of warp strands is interwoven with the at least one weft strand (252), and/or

Any set of warp strands (250) comprises a greater number of the first warp strands (250) than the second warp strands (250), and/or

The thickness of the first warp yarn strand (250) may be greater than the thickness of the second warp yarn strand.

11. Suturing device (100) according to any one of the preceding claims,

the method is characterized in that:

at least one end portion of the body region (102) comprises the plurality of weft strands (252), while a central portion of the body region (102) comprises a single weft strand (252).

12. The suturing device (100) according to claim 10,

the method is characterized in that:

at least one of the weft strands (252) of the at least one end portion of the body region (102) is more rigid than the weft strands (252) of the central portion of the body region (102), and

wherein the more rigid weft strands (252) comprise braided cords and the weft strands (252) of the central portion of the body region (102) comprise at least one filament.

13. Suturing device (100) according to claim 10 or 11,

the method is characterized in that:

a first weft strand (252) of the plurality of weft strands (252) is thicker than a second weft strand (252) of the plurality of weft strands (252).

14. Suturing device (100) according to any one of the preceding claims,

the method is characterized in that:

the at least one weft strand (252) extends longitudinally from a portion of the body region (102), and/or

Wherein the at least one weft strand (252) extends along at least one edge of a central portion of the body region (102), and/or

Wherein the at least one weft strand (252) extends along opposite edges of a central portion of the body region (102), and/or

Wherein the at least one weft strand (252) of the at least one end region (104, 106) comprises at least one corded construction.

15. The suturing device (100) according to the preceding claim,

the method is characterized in that:

at least one end portion of the at least one corded construction is hollow, and

wherein free ends of the warp strands (250) of the at least one end region (104, 106) are locatable inside the at least one corded construction by one or more twist splices to define at least one corded end region (104, 106).

16. A method of manufacturing a suturing device, the method comprising:

interweaving at least one weft strand (252) with a plurality of warp strands (250) to define an open mesh configuration; and

applying tension to the at least one weft strand (252) to urge the warp strands (250) together and define a body region (102) having an open mesh configuration and at least a first elongate end region (104, 106) extending axially from and being a part of the body region (102), the at least first elongate end region having a closed mesh configuration and a width less than the width of the body portion.